Clinical, Microbiological and Biochemical Effectiveness of Full-mouth Treatment Approaches in Severe Chronic Periodontitis: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- GCF osteocalcin
研究概览
简要总结
This study aimed to compare the effects of full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD) on clinical, microbiologic and biochemical parameters with conventional quadrant-wise scaling and root planning (Q-SRP) in patients with severe chronic periodontitis. 60 patients with severe chronic periodontitis were randomly allocated to three groups: FMD (n=20), FMUD (n=20) and Q-SRP (n=20). At baseline, gingival crevicular fluid (GCF) and subgingival plaque were collected and clinical periodontal parameters were recorded. Ultrasonic debridement was completed within 24 hours in FMD and FMUD groups. Chlorhexidine gluconate was used for FMD. Q-SRP was performed by hand instruments per quadrant at 1-week-intervals. Clinical parameters were recorded and samples were collected at 1, 3, 6 months after treatment. Real-time PCR was used for quantitative analysis of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Fusobacterium nucleatum and total bacteria count. Calprotectin, osteocalcin and cross-linked N-telopeptide of type I collagen (NTx) levels in GCF were analysed by enzyme-linked immunosorbent assay.
详细描述
Study population and clinical examination
60 consecutive severe chronic periodontitis patients were recruited for the study.
The whole mouth clinical periodontal examination included measurement of probing depth, clinical attachment level and plaque index at 6 sites per tooth, except the third molars The papillary bleeding index was recorded for the entire oral cavity. Clinical periodontal parameters were recorded at baseline and 1 month, 3 months and 6 months after treatments. Alveolar bone loss were assessed using an digital panoromic radiograph in each participant.
The diagnosis of severe chronic periodontitis was based on clinical and radiographic diagnostic criteria proposed by 1999 International Workshop for a Classification of Periodontal Diseases and Conditions. These individuals had a minimum of four non-adjacent teeth with sites with PD ≥6 mm and CAL ≥5 mm. They had also ≥50% alveolar bone loss in at least two quadrants that was commensurate with amount of plaque accumulation.
All clinical measurements, GCF and plaque sampling and also all treatments were performed by the same calibrated and trained investigator (B.A.) in a standardized manner (single-blinded trial).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged ≥35 years
- •non-smokers
- •having at least 15 natural teeth.
排除标准
- •having any diagnosed medical disorder.
- •taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers within the past 6 months.
- •patients with a history of sensitivity to chlorhexidine.
- •nonsurgical/surgical periodontal treatment received in the past year
- •having a restorative and endodontic therapy requirement
- •having a removable partial denture and/or orthodontic appliances
- •current pregnancy or lactation.
结局指标
主要结局
GCF osteocalcin
时间窗: Change from baseline to 1,3 and 6 months after treatment.
Osteocalcin (ng) levels in GCF.
GCF calprotectin
时间窗: Change from baseline to 1, 3 and 6 months after treatment.
Calprotectin (pg) levels in GCF.
GCF NTx
时间窗: Change from baseline to 1,3 and 6 months after treatment.
NTx (nM BCE) levels in GCF.
次要结局
未报告次要终点
研究者
Beral Afacan
Principal Investigator
Aydin Adnan Menderes University